G/TBT/N/PHL/299  
1 February 2023  
(23-0712) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  PHILIPPINES  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
DR. SAMUEL A. ZACATE  
Director General  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notific ation shall be indicated if different from above:   
JESUSA JOYCE N. CIRUNAY, RPh  
Director IV  
Center for Drug Regulation and Research  
Food and Drug Administration  
DEPARTMENT OF HEALTH  
Email: cdrr.od@fda.gov.ph  ; cdrr.sds@fda.gov.ph  ; bps@dti.gov.ph  
www.fda.gov.ph   
3. Notified under Article 2.9.2 [  ], 2.10.1 [X], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
equipment (ICS code(s): 11.040); Pharmaceutics (ICS code(s): 11.120)  
5. Title, number of pages and language(s) of the notified document:  Updated 
Guidelines for Availing Compassionate Special Permit for the Restricted Use of 
Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices; (11 
page(s), in English)  
6. Description of content:  The proposed policy aims to repeal the current policy on the 
national guidelines for availing a Compassionate Special Permit (CSP) for the restricted 
use of unregistered or unauthorized drug products inc luding vaccines and medical 
devices, and provide the updated guidelines which allows additional covered products and 
medical condition, and streamlines the submission of applications and post -approval 
commitment reports to ensure compliance of CSP applican ts and holders to the 
requirements.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Currently, the policy on CSP does not include vaccines in the list of health 
products which may be given CSP. There is a need to cons ider the inclusion of 
compassionate use of unregistered vaccines, in cases where there are no existing 
treatment alternatives, and where benefits of using such vaccines outweigh the risks. This G/TBT/N/PHL/299  
 
- 2 - 
 
  would allow the immunization of certain vulnerable populations , including our healthcare 
providers who are at the frontlines, during public health emergencies and public health 
threats brought about by emerging infectious diseases.  
Likewise, patients suffering from rare diseases and other diseases that could lead to 
permanent medical impairment are not covered by the current policy and should thus be 
considered for inclusion in line with the original intent of the policy.; Protection of human 
health or safety  
8. Relevant documents:   
• Administrative Order No. 4 s. 1992: Policy Requirements for Availing 
Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug and 
Device Product/ Preparation  
• AO No. 2020 -0028: Amendment to Administrative Order No. 4 s. 1992: Policy 
Requirements for Availing Compassion ate Special Permit (CSP) for Restricted Use 
of Unregistered Drug and Device Product/ Preparation  
9. Proposed date of adoption:  2nd Quarter of 2023  
Proposed date of entry into force:  2nd Quarter of 2023  
10. Final date for comments:  9 February 2023  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Mr. Neil P. Catajay  
Director  
Bureau of Philippine Standards  
Department of Trade and Industry  
3F Trade and Industry Building  
361 Sen. Gil Puyat Avenue  
Makati City  
Philippines  
Tel: (632) 751 4700; (632) 7913128  
Email: bps@dti.gov.ph  
Website: http://www.bps.dti.gov.ph  
https://www.fda.gov.ph/draft -for-comments -updated -guidelines -for-availing -
compassionate -special -permit -for-the-restricted -use-of-unregistered -or-unauthorized -
drug-products -including -vaccines -and-medical -devices/  
https://members.wto.org/crnattachments/2023/TBT/PHL/23_0794_00_e.pdf